Remicade® Treatment Registry Across Canada in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 556
- 主要终点
- Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).
研究概览
简要总结
This registry is a multi-center, prospective, observational program that will gather and analyze data on subjects with Crohn's disease being treated with Remicade® as per approved product monograph in Canada. In contrast to a controlled clinical trial, there is no imposed experimental intervention and treatment with Remicade® is determined solely by the subject's physicians. Thus, the data captured and reported in this registry will reflect a "real world" approach to the treatment of Crohn's disease with Remicade®.
详细描述
Subjects will be selected for this registry using a non-probability sampling method.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient was given the Patient Information Brochure; AND,
- •Patient has never been treated with Remicade® (patient is naïve to Remicade® at the time of registration); AND,
- •Patient is a good candidate to receive Remicade® as per the product monograph; AND,
- •Patient has agreed to complete the Patient Diary for one week prior to each visit in the registry; AND,
- •Patient has signed the approved consent form.
排除标准
- •Per product monograph
结局指标
主要结局
Clinical Response at 12 Months (Decrease in Crohn's Disease Activity Index [CDAI]>= 70 Points AND >= 25% From Baseline).
时间窗: 12 months after baseline
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is \< 150, and moderate to severe disease ranges from 220 to 450.
Clinical Response at 24 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).
时间窗: 24 months after baseline
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is \< 150, and moderate to severe disease ranges from 220 to 450.
Clinical Response at 36 Months (Decrease in CDAI >= 70 Points AND >= 25% From Baseline).
时间窗: 36 months after baseline
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is \< 150, and moderate to severe disease ranges from 220 to 450.
Clinical Remission at 12 Months (CDAI <= 150 Points).
时间窗: 12 months after baseline
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is \< 150, and moderate to severe disease ranges from 220 to 450.
Clinical Remission at 24 Months (CDAI <= 150 Points).
时间窗: 24 months after baseline
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is \< 150, and moderate to severe disease ranges from 220 to 450.
Clinical Remission at 36 Months (CDAI <= 150 Points).
时间窗: 36 months after baseline
CDAI is calculated based on 8 factors: # of liquid stools, abdominal pain, patient well-being, Crohn's complications, need for anti-diarrheal medications, abdominal mass, hematocrit, and weight. CDAI can range from 0 to 600. Remission is \< 150, and moderate to severe disease ranges from 220 to 450.
次要结局
- Number of Serious Adverse Events(Throughout study (up to 36 months))